User Manual
Table Of Contents
- Edora 8
- Table of Contents
- 1 Product Description
- 2 General Safety Instructions
- 3 Implantation
- Implantation Procedure
- Having parts ready
- Keeping an external defibrillator ready
- Unpacking the device
- Checking parts
- Implantation site
- Overview: Implanting
- Avoid damage to the header
- Preventing short circuits in the header
- Keeping distance between leads
- Connecting the lead connector to the device
- Applying the programming head
- Establishing wandless telemetry
- Auto-initialization
- Behavior during auto- initialization
- Precautionary Measures while Programming
- Checking the device system
- Performing standard tests and monitoring the patient
- Do not interrupt wandless telemetry during a treatment
- Cancelling telemetry
- Avoiding critical parameter settings
- Manually setting lead polarity
- Setting sensing
- Setting the sensitivity
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Phrenic nerve stimulation that cannot be terminated
- Avoiding risks in the case of exclusive left ventricular pacing
- If an ICD is implanted at the same time, do not permit unipolar pacing
- Recognizing lead failure
- Consider power consumption and service time
- Magnet Response
- Follow-up
- Patient Information
- Replacement Indications
- Explantation and Device Replacement
- Implantation Procedure
- 4 Parameters
- 5 Technical Data
42
Technical Data
Legend for the Label
Legend for the Label
The label icons symbolize the following:
Manufacturing date Use by
Storage temperature Order number
Serial number Product identification
number
CE mark
Contents Follow the instructions for
use
Sterilized with ethylene oxide
Do not resterilize Single use only.
Do not re-use!
Do not use if packaging is
damaged
Non-sterile
Transmitter with non-ionizing radiation
at designated frequency
Label icon on devices with ProMRI
®
:
MR conditional: Patients having a device
system implanted whose components
are labeled with this symbol on the
packaging can be examined using an MR
scan under precisely defined conditions.
TP2 Compabiltiy with telemetry protocol version 2
of BIOTRONIK Home Monitoring
Example
Uncoated device: NBG code and
compatible leads
Screwdriver
Examples of the connector allocation: IS-1, IS-1/IS4
NON
STERILE